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  • MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
  • The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
  • MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.
    • Search MAUDE Database
    Help | Download Files | More About MAUDE
    Enter a search term below, choose a date range and select Search

    Enter a single word (e.g., electromechanical), an exact phrase (e.g., electromechanical pump) or multiple
    words. To Search by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code,
    or date, select Go To Advanced Search button.
     
               

    Medical Device Reporting Search: (for incidents before July 31, 1996)

    Database last updated on June 30, 2008

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